Impact of Platelet Concentration in PRP on TMJ Subluxation

NCT07532798 | Completed

• 1 other identifier: CU-TMJ-PRP-RCT-2016
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief Summary

This study is about a treatment for a jaw condition called temporomandibular joint (TMJ) subluxation. In this condition, the jaw can move too far forward during mouth opening, which may cause repeated jaw locking and problems with normal function. The treatment being studied is platelet-rich plasma (PRP) injections. PRP is made from a person's own blood and may help improve joint stability and reduce symptoms. In this study, 40 adults with TMJ subluxation were randomly assigned to receive PRP with either a lower or higher platelet concentration. Each participant received 2 injections, given 2 weeks apart. The study measured jaw pain, how often locking happened, mouth opening, and joint clicking before treatment, after 6 months, and after 5 years. The goal of this study is to find out whether the amount of platelets in PRP changes how well this treatment works.

Conditions

Temporomandibular Disorders (TMDs)

Keywords

TMJ subluxation; Temporomandibular joint subluxation; TMJ hypermobility; Recurrent TMJ dislocation; Platelet-rich plasma; PRP prolotherapy

Outcome Measures

Primary Outcomes (2)

• TMJ Pain on Function

  Pain during jaw function measured using a visual analog scale (VAS) from 0 to 10, where 0 indicates no pain and 10 indicates worst pain.

  Baseline, 6 months, and 5 years

• Frequency of TMJ locking

  Frequency of locking, expressed as number of episodes per day

  Baseline, 6 months, and 5 years

Secondary Outcomes (2)

• Maximum mouth opening (MMO)

  Baseline, 6 months, and 5 years

• Presence of joint clicking

  Baseline, 6 months, and 5 years

Study Arms (2)

Low Platelet Concentration PRP (L-PRP)

ACTIVE COMPARATOR

Patients received prolotherapy using platelet-rich plasma with low platelet concentration.

Procedure: Low Platelet Concentration PRP (L-PRP)

High Platelet Concentration PRP (H-PRP)

ACTIVE COMPARATOR

Patients received prolotherapy using platelet-rich plasma with high platelet concentration.

Procedure: High Platelet Concentration PRP (L-PRP)

Interventions

Low Platelet Concentration PRP (L-PRP) PROCEDURE

Intra-articular and pericapsular injection of platelet-rich plasma prepared with Low platelet concentration..

Low Platelet Concentration PRP (L-PRP)

High Platelet Concentration PRP (L-PRP) PROCEDURE

Intra-articular and pericapsular injection of platelet-rich plasma prepared with high platelet concentration.

High Platelet Concentration PRP (H-PRP)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

Sponsors & Collaborators

• IBB University: lead

Study Sites (1)

Oral and Maxillofacial Surgery Department, Faculty of Dentistry, Cairo University

Cairo, Egypt

Location

MeSH Terms

Conditions

Temporomandibular Joint Disorders

Condition Hierarchy (Ancestors)

Craniomandibular Disorders; Mandibular Diseases; Jaw Diseases; Musculoskeletal Diseases; Joint Diseases; Muscular Diseases; Stomatognathic Diseases

Study Officials

• Hamida Refai, PhD

  Cairo University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Masking Details: Participants and outcome assessors were blinded to group allocation. The clinician performing the intervention was not blinded due to the nature of the procedure.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor of Prosthodontics

Study Record Dates

• First Submitted: April 2, 2026
• First Posted: April 16, 2026
• Study Start: April 1, 2016
• Primary Completion: January 1, 2017
• Study Completion: July 1, 2017
• Last Updated: April 16, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)